2023-2024 SOCRA Annual Report - Flipbook - Page 12
SOCRA 2021 ANNUAL REPORT
EDUCATION + TRAINING
THE IMPORTANCE OF TRAINING IN THE CONDUCT OF CLINICAL TRIALS
FDA Center for Drug Evaluation and Research (CDER) final
classifications for Clinical Investigator Inspections continue to show
trends in clinical investigator deficiencies in areas such as protocol
deviations, subject enrollment, informed consent, and safety reporting.
SOCRA recognizes these trends and issues and offers education for
clinical research professionals on Good Clinical Practice (GCP) and
more. Our hope is that by participating in SOCRA programming, our
members will be leaders in the clinical research profession and that
inspection findings will continue to improve.
EDUCATION BROUGHT TO YOU AT YOUR SITE
In addition to our numerous offerings throughout the US and Canada,
SOCRA will schedule the Certification Preparation and GCP Review Course
at your site for a minimum of 20 guaranteed participants. SOCRA can also
customize our educational offerings to meet the needs of your research site /
institution. SOCRA has held education programs in the U.S.A., Canada,
Mexico, Brazil, Japan, Belgium, Korea, and Singapore. And now many of our
programs are transitioning to be offered virtually!
Final Classifications for Clinical Investigator Inspections
FY 2017 to 2020
750
500
250
0
NAI
2017
VAI
2018
OAI
2019
2020
SOCRA PROGRAMS MEET INDUSTRY CRITERIA FOR ICH GCP INVESTIGATOR SITE PERSONNEL TRAINING
Clinical researchers who hold the SOCRA “CCRP,” Certified Clinical
Research Professional designation, as well as those clinical researchers
who complete specific SOCRA GCP courses (noted below), meet the
minimum criteria for ICH GCP investigator site personnel training as
identified by TransCelerate BioPharma member companies.
SOCRA “CCRP” Certification Preparation & GCP Review Course
Clinical Site Coordinator/ Manager Workshop GCP for
Coordinators, Research Associates, Study Nurses, Site
Managers
Conducting Clinical Trials in Canada
Clinical Investigator GCP & Trials Management Conference for
Clinical Investigators and Key Research Staff
SOCRA OFFERS CME AND CNE
TransCelerate BioPharma Inc. was launched in 2012
as a non-profit organization with a mission to
collaborate across the biopharmaceutical research
and development community to identify, prioritize,
design and facilitate the implementation of
solutions to drive efficient, effective and high-quality
delivery of new medicines, improving the health of
people around the world.
In addition to offering the highest quality training programs for
clinical research professionals, SOCRA is a provider of CME and CNE
(Continuing Medical Education and Continuing Nurse Education) in
addition to SOCRA CE for SOCRA recertification.
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